11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioseal Inc.
FDA UDI
BIOSEAL·00630094196312·Latex Tubing Ext. w/connector
COLOR LCD MONITOR, RADIFORCE, MODEL RX210
FDA 510(k)
FDA Class 2
·Radiology
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 19, 2014
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·February 15, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 18, 2011
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·April 9, 2014
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·March 24, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·February 20, 2014
BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018